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Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19 (COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467047
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm. Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV2 Biological: Mesenchymal Stromal Cells infusion Phase 1

Detailed Description:
Coronavirus-19 Disease (COVID-19), caused by the Sars-Cov-2 virus, which occurs as a growing pandemic in early 2020 and currently represents an emergency state worldwide. Several reports have shown that the first step in the pathogenesis of Sars-Cov-2 is the recognition of the angiotensin I converting enzyme (ACE2) receptor by the virus. This ACE2 receptor is widely distributed on the surface of human cells, especially as type II alveolar cells and capillary endothelium, however bone marrow, lymph nodes, thymus and spleen are known as immune cells, such as T and lymphocytes. B and macrophages, are negatives to ACE2. These results suggest that immunotherapy can be used to treat infected patients. However, an immunomodulatory capacity cannot be so strong, if just one or two major immunological factors used, as the virus can cause a "cytokine storm", such as IL-2, IL-6, IL-7, GSCF, IP10 , MCP1, MIP1A and TNFα, followed by edema, gas exchange dysfunction, acute respiratory distress syndrome, cardiac injury and secondary infection that can lead to death. Therefore, avoiding a "cytokine storm" may be the key to treating patients infected with Sars-Cov-2. Mesenchymal stem cells (MSCs), due to their potential for immunomodulatory activity, can have beneficial effects in preventing or attenuating the cytokine storm. Because MSCs have been widely used in cell therapy, from basic research to clinical trials. Safety and efficacy have been clearly documented in several clinical trials, especially in immune-mediated inflammatory diseases, such as graft versus host disease (GVHD). The objective of the study is to verify the safety and feasibility of using allogeneic bone marrow mesenchymal stem cells in patients with SARS-CoV-2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Allogenic Mesenchymal Stromal Cells in the Treatment of COVID-19
Estimated Study Start Date : July 25, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Intervention
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
Biological: Mesenchymal Stromal Cells infusion
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 60 days ]
    Assessment of Overall survival at 30 days post intervention


Secondary Outcome Measures :
  1. Changes on inflammatory C-reactive protein [ Time Frame: 60 days ]
    To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)

  2. Hospital stay [ Time Frame: 60 days ]
    days of the patients in hospital

  3. Oxygenation index (PaO2/FiO2) [ Time Frame: 60 days ]
    Evaluation of functional respiratory changes: PaO2 / FiO2 ratio

  4. Improvement in Liao's score (2020) [ Time Frame: 60 days ]
    Improvement in Liao's score (2020)

  5. Radiological improvement [ Time Frame: 60 days ]
    Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19

  6. Time of COVID19 PCR negativity [ Time Frame: 28 days ]
    PCR testing to check PCR negativity



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR)
  • The patient or legal donor agrees to participate in the study and signs the informed consent.
  • Patients with orange or red criteria according to the score proposed by Liao et al (2020)

Exclusion Criteria:

  • Patient with pregnancy, are planning to become pregnant or breastfeeding
  • Patients with malignant blood-borne diseases such as HIV or syphilis
  • Not consenting for clinical trial
  • Patients with other than orange or red criteria according to the score proposed by Liao et al (2020)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467047


Contacts
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Contact: Lucia Silla, MD, PhD 55 51 33598371 lsilla@hcpa.edu.br
Contact: Annelise Pezzi, PhD annepezzi@gmail.com

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Lucia Silla, MD, PhD Hospital de Clinicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04467047    
Other Study ID Numbers: 20200148
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Mesenchymal Stromal Cells
COVID-19
Sars-CoV2